FDA Inspection
PAI Holdings, LLC. dba Pharmaceutical Associates IncPAI Holdings, LLC. dba Pharmaceutical Associates Inc – FDA Inspection, Aug 24, 2009
Record Details
This FDA Inspection record concerns PAI Holdings, LLC. dba Pharmaceutical Associates Inc, with an inspection on August 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 24, 2009
- Product Type
- Drugs
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ID · 06fd0b13-48d8-4365-8ca0-68e769346d7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611641
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PAI Holdings, LLC. dba Pharmaceutical Associates Inc
17| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | Not classified | Atlanta District Office | |
| January 28, 2025 | Not classified | Atlanta District Office | |
| August 2, 2023 | NAI | Atlanta District Office | |
| September 15, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 6, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PAI Holdings, LLC. dba Pharmaceutical Associates Inc
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- FDA Inspection 1211228 - 2023-08-02
- FDA Inspection 1152192 - 2021-09-15
- FDA Inspection 1121101 - 2020-02-06
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